Morgan Scientific, Inc.

Morgan Scientific, Inc. specializes in professional diagnostic spirometers and computerized pulmonary analysis systems. These devices are designed for clinical use to measure lung function metrics like airflow, lung volume, and spirometry parameters. Examples include portable and bench-top models such as the ComPAS series, BODY BOX 5500, and SPIRO'AIR, which incorporate digital analysis for improved diagnostic accuracy in conditions like asthma and COPD.

Morgan Scientific, Inc. is based in the United States. Its devices are regulated under the FDA’s classification system, with most falling under Class II, which requires premarket notification (510(k)) or de novo clearance for market authorization. This classification reflects the moderate risk associated with these diagnostic tools, ensuring they meet safety and performance standards before use in clinical settings.

Morgan Scientific, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) registry tracks premarket notifications for Class II devices, while the UDI system ensures traceability and compliance by assigning unique identifiers to each device type. These listings help healthcare providers and regulators verify the authorized status of specific models like the ComPAS series or BODY BOX 5500.

Morgan Scientific, Inc.’s devices are classified as FDA Class II, which is the second-highest risk category for medical devices in the U.S. This classification applies to diagnostic spirometers and pulmonary analysis systems because they pose moderate risks if they malfunction, such as providing inaccurate lung function readings. As a result, these devices require premarket submission (like a 510(k)) to demonstrate substantial equivalence to a legally marketed predicate device or, in rare cases, de novo classification for innovative technologies.